Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Approximately 4,500 people in the U.S.

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The Pharma Data

NOVEMBER 23, 2021

Approval is for Cytomegalovirus, a Type of Herpes Virus. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today, the U.S. It’s a type of herpes contagion.

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Drug Discovery World

SEPTEMBER 14, 2023

8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study. References Wong MCS, et al. Erdafitinib for the treatment of metastatic bladder cancer. Expert Review of Clinical Pharmacology.

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past.

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Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. What evidence is there that we can reverse aging with drugs?

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The Pharma Data

SEPTEMBER 1, 2021

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S.

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Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. Women’s health microbiome-based drug development landscape Despite their limited historical interest, pharma/biotech companies are now increasingly interested in the female microbiome and its role in drug development.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. Drug Enforcement Administration.

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Drug Discovery World

MARCH 7, 2023

For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. Dr Janette Thomas, CEO, Five Alarm Bio Five Alarm Bio is an anti-ageing therapeutics company, which completed a seed investment round in early 2023.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. is a leading global pharmaceutical company headquartered in Japan. Biogen (Nasdaq: BIIB) and Eisai Co., Tokyo, Japan) today announced the U.S. About Eisai Co.,

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. HELLERUP, Denmark , Jan.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. So design quality is linked to product performance.

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion mutations. About Takeda Pharmaceutical Company Limited.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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The Pharma Data

DECEMBER 1, 2020

Genesis is progressing both an internal drug pipeline, as well as select external partnerships, to create transformative therapies for patients. We are united in our view that drug discovery and development must raise its success rate. Feinberg, Ph.D., Genesis’ CEO and co-founder. “We

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The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

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The Pharma Data

DECEMBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. , (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. Company Information. RANCHO CUCAMONGA, Calif.,

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Dark Matter Blog

AUGUST 27, 2020

A few years ago, at Arrakis Therapeutics, we set out to conquer a strange new territory, drugging RNA structures with small molecules. In fact, it was these early pharmaceutical successes that gave us the confidence that we would ultimately succeed in systematically drugging a wide range of RNA structures.

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The Pharma Data

JANUARY 13, 2021

Nasdaq: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders and diseases, today announced that it has priced an underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $2.50 SOLANA BEACH, Calif., 13, 2021 (GLOBE NEWSWIRE) — Evoke Pharma, Inc.

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Policy Prescription

FEBRUARY 9, 2022

Mark Cuban’s new online pharmacy venture – the Mark Cuban Cost Plus Drug Company (“Cost Plus Drug”) – will not help overcome the biggest obstacle to drug affordability in America, which is drug company monopolies on patented brand name prescription drugs. Enter Cuban’s Cost Plus Drug.

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The Pharma Data

MARCH 26, 2021

If approved, ponesimod will be the first therapy by Janssen for patients living with RMS with active disease defined by clinical or imaging features. Ponesimod is a highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes. [7]

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The Pharma Data

DECEMBER 16, 2020

–( BUSINESS WIRE )– ANI Pharmaceuticals, Inc. , (“ANI” or the “Company”) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval and the launch of Aminocaproic Acid Tablets USP, 500mg. ANI Pharmaceuticals, Inc. BAUDETTE, Minn.–( The current annual U.S.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

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The Pharma Data

JANUARY 19, 2021

Kura Oncology’s other, more advanced, program focuses on tipifarnib, a drug that originally was developed by Janssen, and which has shown impressive clinical benefits as a monotherapy in patients with HRAS mutant head and neck squamous cell carcinoma (HCSCC). Tipifarnib is a farnesyltransferase inhibitor (FTI). dependent HNSCC.

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Drug Discovery World

AUGUST 10, 2023

Achieve Life Sciences is a specialty pharmaceutical company committed to addressing the global smoking health and nicotine addiction epidemic through the development and commercialisation of cytisinicline. As such, the company has achieved some key milestones this year. appeared first on Drug Discovery World (DDW).

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Advarra

JULY 19, 2022

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. The sponsor is the pharmaceutical company conducting the trial.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. DRUG INTERACTIONS. Effect of ERLEADA ® on Other Drugs — ERLEADA ® is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. ERLEADA ® received U.S.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Nuance Pharma .

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Both products were licensed from Ligand Pharmaceuticals. About Sesquient.

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The Pharma Data

OCTOBER 21, 2020

The long-acting regimen of cabotegravir and rilpivirine was approved by Health Canada in March 2020 and is currently under review by the US Food and Drug Administration and other global regulatory authorities. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK . Source link.

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Drug Discovery World

JANUARY 11, 2023

Supported by landmark clinical data from a Phase III trial, next-in-class anti-Aβ monoclonal antibody (MAb) lecanemab appears poised for full US FDA approval and ex-US launches. Teclistamab (TECVAYLI/JNJ-64007957) developed by Janssen Pharmaceutical Companies of Johnson & Johnson. The report.

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JANUARY 17, 2021

Guardant360 ® tests are used by oncologists around the world to guide treatment decisions across solid tumor cancers, and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development. Guardant Health has achieved CE mark approval as well as U.S.

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. The studies demonstrated that CABENUVA was as effective as continuing a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period. TITUSVILLE, N.J. ,

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